DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/14/2026 has been entered.
Election/Restrictions
Newly submitted claims 61-84 are directed to an invention that lacks unity with the invention originally claimed for the following reasons:
The claims now contain the following inventions:
Group I, claims 1-12, drawn to a biochip comprising at least one cylindrical ductal scaffold supported by at least one chassis, an internal compartment defined by the at least one cylindrical ductal scaffold; an external compartment external to the at least one cylindrical ductal scaffold; at least one lumen microfluidic channel providing access to the internal compartment; and at least one external microfluidic channel providing access to the external compartment (originally presented invention).
Group II, claims 61-72, drawn to a biochip comprising first and second cylindrical ductal scaffolds supported by at least one chassis, wherein the at least one chassis defines at least one internal compartment within the second cylindrical ductal scaffold and at least one external compartment outside the second cylindrical ductal scaffold, and at least one microfluidic channel provides independent access to the at least one internal compartment or the at least one external compartment.
Group III, claims 73-84, drawn to a biochip comprising at least one cylindrical ductal scaffold supported by at least one chassis; an internal space external to the at least one cylindrical ductal scaffold; an internal compartment of the at least one cylindrical ductal scaffold; at least one microfluidic channel engraved on an outer surface of the at least one chassis providing access to the internal space; and at least one lumen microfluidic channel providing access to an internal compartment of the at least one cylindrical ductal scaffold.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I, II, and III lack unity of invention because even though the inventions of these groups require the technical feature of a biochip for growing ductal tissue, the biochip comprising: at least one chassis; at least one cylindrical ductal scaffold supported by the at least one chassis, the at least one cylindrical ductal scaffold comprising at least one porous membrane; an internal space provided within the at least one chassis and external to the at least one cylindrical ductal scaffold, the internal space defining an external compartment relative to the at least one cylindrical ductal scaffold; at least one microfluidic channel providing access to the internal space; and at least one lumen microfluidic channel providing access to an internal compartment of the at least one cylindrical ductal scaffold, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Nath et al. (US Patent Application Publication 2018/0066220). Nath et al. discloses a biochip (called microfluidic device, para. 3, has the form of a chip, see Fig. 2, sheet 2 of 15) for growing ductal tissue (the device is fully capable of growing ductal tissue, see para. 90-93), the biochip comprising: at least one chassis (comprising device layers 33 and 36 which read on at least one chassis as the layers form a body of the device, see para. 47 and Fig. 2, sheet 2 of 15), at least one cylindrical ductal scaffold (the hollow fiber, or HF, is cylindrical and serves as a cell scaffold, see Abstract, para. 47, and Fig. 2, wherein the scaffold is fully capable of being for ductal cells, see para. 90-93) supported by the chassis (para. 27) (Fig. 2), the at least one cylindrical ductal scaffold comprising at least one porous membrane (para. 6, 40); an internal space (called chamber) provided within the at least one chassis and external to the at least one cylindrical scaffold (para. 47) (Fig. 2), the internal space defining an external compartment relative to the at least one cylindrical ductal scaffold (para. 47) (Fig. 2); at least one microfluidic channel providing access to the internal space (para. 3, 47) (Fig. 2); and at least one lumen microfluidic channel providing access to an internal compartment of the at least one cylindrical scaffold (para. 47) (Fig. 2).
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 61-84 have been withdrawn from consideration as being directed to a nonelected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Arguments
Applicant's arguments filed 04/14/2026 have been fully considered but they are not persuasive.
Applicant has argued that Nath does not disclose a cylindrical ductal scaffold formed from a porous membrane; specifically, Applicant argues that the hollow fiber disclosed by Nath cannot read on this limitation as it is a prefabricated hollow fiber. The Examiner respectfully disagrees, because the claim limitation does not introduce any feature that structurally distinguishes the claimed scaffold from the hollow fiber disclose by Nath. Specifically, the hollow fiber disclosed by Nath reads on a cylindrical ductal scaffold formed from a porous membrane because it is cylindrical (para. 40) (Fig. 2), it can culture various cell types including ductal cells (para. 90-93), it is a scaffold (Abstract, para. 93), and it is formed from a porous membrane (para. 6, 40). Whether or not the prior art hollow fiber is prefabricated does not preclude it from reading on the cylindrical ductal scaffold defined in claim 1.
Applicant has argued that the claimed device architecture is different than that of Nath; however, Nath does in fact disclose a cylindrical ductal scaffold (the hollow fiber) positioned within a chamber formed in a device layer (mapped to the claimed chassis), such that there is a space within the cylindrical ductal scaffold and another space external to the cylindrical ductal scaffold but within the chamber (para. 46) (Fig. 2). Furthermore, Nath is directed to applying different conditions to the space within the hollow fiber and the chamber space external to the hollow fiber for experimental purposes (para. 10, 40, 82). Therefore, the Examiner asserts that there is no structural difference between the chassis architecture defined in claim 1 and that of Nath.
Applicant has argued that Nath does not disclose an engraved microfluidic channel covered by a cover slip; however, the Examiner asserts that microfluidic channel 35 reads on an engraved channel (para. 47, 65) (Fig. 2) and it is enclosed by layers 36 and 37 to define the channel (para. 47) (Fig. 2) (either of these layers would read on a cover slip as they serve to cover channels).
Applicant has argued that Nath does not disclose wherein the external compartment is serviced by a dedicated external microfluidic channel. This argument is not commensurate in scope with claim 1 as currently worded. Nonetheless, the Examiner notes that Nath discloses various microfluidic channels that communicate with an external compartment (channels 35 and 32 communicate with a chamber space external to the hollow fiber indirectly, see para. 42, 47; the channels extending from ports 28 and 39 communicate with the chamber directly, see para. 47 and Fig. 2).
As to Applicant’s argument that Nath does not disclose wherein the ductal scaffold is formed from a planar membrane substrate curved into a closed loop of cylindrical cross- section and bonded along a longitudinal seam forming a flat bonded area along the surface of the scaffold, this subject matter is newly presented by way of amendment and will be addressed below.
Claim Objections
Claim 9 is objected to because of the following informalities:
In claim 9, change “coverslip” to “cover slip” to match the style of claim 1.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 12 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 12 has been amended so as to recite “wherein at least one pore allows diffusion of biological components across a wall of the at least one cylindrical ductal scaffold, enabling cell migration, cell-cell interaction, biological exchange, and formation of a tight ductal barrier” (emphasis added). However, support for the limitation of forming a tight ductal barrier could not be found in the specification as-filed.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “tight” in claim 12 is a relative term which renders the claim indefinite. The term “tight” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 5-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nath et al. (US Patent Application Publication 20180066220) (already of record).
Regarding claim 1, Nath et al. discloses a biochip (called microfluidic device, para. 3, has the form of a chip, see Fig. 2, sheet 2 of 15) for growing ductal tissue (the device is fully capable of growing ductal tissue, see para. 90-93), the biochip comprising:
at least one chassis (comprising device layer 33) (para. 47) (Fig. 2);
at least one cylindrical ductal scaffold (called hollow fiber or HF, reads on a cylindrical ductal scaffold as it is cylindrical, it can culture various cell types including ductal cells, and it is a scaffold, see Abstract, para. 40, 47, and 90-93, and Fig. 2) supported by the at least one chassis (para. 47) (Fig. 2), the at least one cylindrical ductal scaffold comprising at least one porous membrane (para. 6, 40, 45), wherein the at least one cylindrical ductal scaffold defines an internal compartment (para. 10, 40) (Fig. 2), and wherein the at least one chassis is configured such that an internal space is provided within the at last one chassis and external to the at least one cylindrical ductal scaffold (chamber 23 is provided within the at least one chassis and comprises a space therein that is external to the hollow fiber 31, see para. 47 and Fig. 2), the internal space defining an external compartment relative to the at least one cylindrical ductal scaffold (para. 10, 47) (Fig. 2);
at least one lumen microfluidic channel providing access to the internal compartment (any of channels 35 or tubing 32 would read on a lumen microfluidic channel providing access to the internal compartment as each of these elements comprises a lumen having microfluidic dimensions and provides access to an internal compartment of the hollow fiber, see para. 5, 47 and Fig. 2);
at least one external microfluidic channel providing access to the external compartment (any of channels 35 read on an external microfluidic channel providing access to the external compartment, as each of these elements are microfluidic channels external to the chamber 34, and each is in fluid communication with the external compartment via pores in the hollow fiber, see para. 5, 45, 47, and Fig. 2); and
at least one cover slip cooperating with the at least one chassis to enclose at least a portion of the at least one external microfluidic channel (either top layer 36 or bottom layer 37 reads on the cover slip as each of these elements serve as an outer boundary to enclose the microfluidic channels) (para. 47, 65-67) (Fig. 2).
Regarding claim 5, Nath et al. discloses wherein a plurality of openings are provided on the at least one chassis to allow fluid or air to enter or exit the external compartment (layer 36 is interpreted to form part of the chassis; this layer comprises openings 38 and 39 to allow fluid or air to enter or exit the external compartment, see para. 47 and Fig. 2).
Regarding claim 6, Nath et al. discloses wherein the at least one chassis contains features that hold the at least one cylindrical ductal scaffold in position while providing access to the internal compartment and the external compartment (para. 45-47) (Fig. 2).
Regarding claim 7, Nath et al. discloses wherein the at least one chassis contains features forming one or more microfluidic channels giving access to the internal compartment and the external compartment (para. 45-47) (Fig. 2).
Regarding claim 8, Nath et al. discloses wherein the at least one external microfluidic channel is engraved in one or more inner layers of the at least one chassis (para. 45-47) (Fig. 2).
Regarding claim 9, Nath et al. discloses wherein the at least one external microfluidic channel is engraved on one or more outer surfaces of the at least one chassis and enclosed by the at least one coverslip to form a full channel (para. 45-47) (Fig. 2).
Regarding claim 10, Nath et al. discloses wherein a cross-section of the at least one cylindrical ductal scaffold is circular (para. 40, 45) (Fig. 2).
Regarding claim 11, Nath et al. discloses wherein the at least one cylindrical ductal scaffold is porous and comprises pores of selected size (para. 45).
Regarding claim 12, Nath et al. discloses wherein at least one pore allows diffusion of biological components across a wall of the at least one cylindrical ductal scaffold (para. 45), enabling cell migration, cell-cell-interaction, and biological exchange (para. 45).
Nath et al. does not expressly teach formation of a tight ductal barrier. Nonetheless, it has been held that a claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim (see MPEP 2114). Nath et al. discloses pores of a size allowing cell migration and cell-cell interaction, as set forth above, and further discloses culturing epithelial cells on the scaffold (para. 24, 41) and therefore the device disclosed by Nath et al. is fully capable of forming a tight ductal barrier, e.g., by culture of cells that form tight junctions such as epithelial or endothelial cells. Therefore, the limitation does not introduce a patentable distinction over the prior art.
Claim Rejections - 35 USC § 102/103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 2 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nath et al. (US Patent Application Publication 20180066220) (already of record), or alternatively, under 35 U.S.C. 103 as being unpatentable over Nath et al. (US Patent Application Publication 2018/0066220) (already of record) in view of Li et al. (Construction of Small-Diameter Vascular Graft by Shape-Memory and Self-Rolling Bacterial Cellulose Membrane).
Regarding claim 2, the entirety of the claim is directed to a recitation of how the at least one cylindrical ductal scaffold is formed. It has been held that the patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (MPEP 2113). In this case, the cylindrical ductal scaffold disclosed by Nath et al. is the same as the product of claim 2, as both have the structure of at least one porous membrane in a closed loop of cylindrical cross-section, formed out of a single layer of material (see para. 40 and Fig. 2 of Nath et al; additionally, the reference is devoid of mention of multiple layers of membrane material). Therefore, Nath et al. anticipates claim 2.
Should it be found that the disclosure of Nath et al. is not sufficient to anticipate claim 2, then it nonetheless would have been obvious to modify the at least one porous membrane disclosed by Nath et al. such that it is formed from a planar membrane substrate curved into a closed loop of cylindrical cross-section, formed out of a single layer of material, based on the teachings of the prior art.
Li et al. discloses a cylindrical cell culture scaffold (Abstract) formed by a planar porous membrane substrate curved into a closed loop (p. 2 col. 2 para. 3-p. 3 col. 1 para. 1) (Fig. 1, p. 3), formed out of a single layer of material (a single planar membrane is curved to form the cylindrical structure, see p. 2 col. 2 para. 3-p. 3 col. 1 para. 1, and Fig. 1, p. 3). Li et al. discloses that providing the scaffold in such a rolled configuration provides a more physiologically accurate cell culture model (p. 1 col. 1 para. 1-p. 2 col. 2 para. 2).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the at least one membrane structure disclosed by Nath et al. to have a rolled configuration, i.e., by using at least one porous membrane formed from a planar membrane substrate curved into a closed loop of cylindrical cross-section, formed out of a single layer of material, as Li et al. discloses that it was known in the art to use such a rolled configuration to enhance the physiological accuracy of a cell culture device, and the skilled artisan would have been motivated to select a membrane configuration that enhances the experimental utility of the device.
Allowable Subject Matter
Claims 3-4 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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/HOLLY KIPOUROS/Primary Examiner, Art Unit 1799
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